Kinapse Blog
Read our latest insights into the Life Sciences industry.
Are you Brexit Ready?
Back to Kinapse blog Are you Brexit Ready? Do you know you only have 12 months to produce an eCTD baseline for your CAPs that have [...]
US Agent & Official Correspondent (OC) Services
US Agent & Official Correspondent (OC) Services Download Kinapse US Agent flyer and learn more about our offerings. Download [...]
FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Summary: The USFDA recently finalized the [...]
US Agent & Official Correspondent (OC) Services
US Agent & Official Correspondent (OC) Services Are you planning to register and market your pharmaceutical, medical device or food and dietary [...]
Kinapse provides expert standalone document quality control services
Back to Kinapse blog Kinapse provides expert standalone document quality control services The number of clinical trials as well as the amount of regulatory documentation [...]
Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines
Lessons Learnt from the Presence of N-nitrosamine Impurities in Sartan Medicines In 2018, the European medicines regulatory network became aware of [...]
Overview of the new drug regulation registration (DRR) in China
Overview of the new Drug Regulation Registration (DRR) in China On the 1st July 2020 the new Drug Regulation Registration [...]
Kinapse welcomes you to ICH Q12
Kinapse welcomes you to ICH Q12 Back to Kinapse blog May 2020 The USFDA has recently released [...]
Kinapse welcomes you to ICH Q12
Kinapse welcomes you to ICH Q12 Back to Kinapse blog April 2020 On 9th April 2020, Swissmedic [...]
Kinapse welcomes you to ICH Q12
Back to Kinapse blog March 2020 On 4th March 2020, EMA published adoption of ICH Q12 guideline along with an [...]
Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities
Kinapse commits to supporting Marketing Authorisation Holders (MAHs) regarding Nitrosamine Impurities The deadline to respond to EMA Art. 5(3) Referral [...]
Kinapse welcomes you to ICH Q12
Back to Kinapse blog December 2019 Kinapse welcomes you to ICH Q12 The key milestone [...]
Kinapse launches Plain Language Summary Portal
Kinapse launches Plain Language Summary Portal Kinapse, a Syneos Health Company, a market leader in clinical trial disclosure services, announced the launch of ClinTrialDataShare.com, a web portal for sponsors to [...]
Product Acquisition: Acquiring a Portfolio of Marketed Products
Learn why requirements for plain-language summaries of clinical studies, aimed at a broad, non-technical audience, could create new risks for sponsors.
The Regulatory Times – June 2019
Your monthly round-up of international Life Sciences regulatory news from the past month. Follow the link to read June's edition from Kinapse.
The Regulatory Times – May 2019
Your monthly round-up of international Life Sciences regulatory news from the past month. Follow the link to read April's edition from Kinapse.
